BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA DR CRT-D, DF-4 CONNECTOR

    MDR report key: 3903742 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12746
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 26, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED FOR A FOLLOW-UP. EPISODES OF NON-SUSTAINED RV OVERSENSING WERE OBSERVED. THE DEVICE WAS INTERMITTENTLY OVERSENSING. PROGRAMMING CHANGES WERE MADE AND RESOLVED THE OVERSENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379958 UNIFY ASSURA DR CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3357-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR